Cisatracurium Noridem

Package leaflet: Information for the user

Cisatracurium Noridem 2 mg/ml solution for injection or infusion

Generic medicine
cisatracurium
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Cisatracurium Noridem is and what it is used for
2. What you need to know before you are given Cisatracurium Noridem
3. How Cisatracurium Noridem is given
4. Possible side effects
5. How to store Cisatracurium Noridem
6. Contents of the pack and other information

1. What Cisatracurio Noridem is and what it is used for

The active substance is cisatracurium besilate. This substance belongs to a group of medicines
called muscle relaxants.
Cisatracurio Noridem is used for:

• Relaxing muscles during surgical procedures in adults and children at least 1 month of age, including heart surgery.
• Facilitating tracheal intubation when a patient requires respiratory support.
• Relaxing muscles in adults undergoing intensive care.
• If you would like further information about this medicine, please consult your doctor.

2. What you need to know before you are given Cisatracurium Noridem

Cisatracurium Noridem must not be administered to you if:

• You are allergic to cisatracurium, to other muscle relaxants, or to any of the other ingredients of this medicine (listed in section 6).
• You have previously experienced an adverse reaction during the use of an anaesthetic.
• If you think any of these conditions apply to you, do not receive Cisatracurium Noridem. If you are unsure, consult your doctor, pharmacist, or nurse before receiving Cisatracurium Noridem.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving this medicine:

• If you have muscle weakness, pain, or difficulty coordinating movements (myasthenia gravis).
• If you have a neuromuscular disease, such as muscular dystrophy, paralysis, motor neuron disease, or cerebral palsy.
• If you have a burn injury requiring medical treatment.

If you are unsure whether any of the above apply to you, consult your doctor or nurse before receiving Cisatracurium Noridem.
Other medicines and Cisatracurium Noridem
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes herbal products or medicines purchased without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• Anaesthetics (used to reduce pain and sensation during surgical procedures).
• Antibiotics (used to treat infections).
• Medicines for irregular heartbeats (antiarrhythmics).
• Medicines for high blood pressure.
• Diuretics, such as furosemide.
• Medicines for joint inflammation, such as chloroquine or d-penicillamine.
• Steroids.
• Medicines for seizures (epilepsy), such as phenytoin or carbamazepine.
• Medicines for mental health disorders, such as lithium or chlorpromazine (which may also be used for nausea).
• Medicines containing magnesium.
• Anticholinesterase agents used in the treatment of Alzheimer's disease, such as donepezil.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before receiving this medicine.
An adverse effect of cisatracurium on infants breastfed cannot be completely ruled out, although this is unlikely if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurium is rapidly eliminated from the body. Women should refrain from breastfeeding for 3 hours after discontinuation of treatment.
Driving and using machines
If you have been admitted to hospital for a day case procedure, your doctor will advise you how long you should wait before leaving the hospital or driving a vehicle. It may be dangerous to drive too soon after undergoing surgery.

3. How Cisatracurium Noridem is administered

You will never be expected to administer this medicine to yourself. It will always be given to you by a qualified healthcare professional.
Cisatracurium Noridem may be administered:

• As a single intravenous injection (intravenous bolus injection).
• As a continuous intravenous infusion. In this way, the medicine is given slowly over a prolonged period of time.
• The doctor will decide the method of administration and the dose required. The dose will depend on the following factors:
  • body weight,
  • the amount and duration of muscle relaxation required,
  • the expected response to the medicine.

Use in children
This medicine must not be administered to children under 1 month of age.
If you receive more Cisatracurium Noridem than you should
Cisatracurium Noridem must always be administered under closely monitored conditions.
However, if you think that you have been given too much of the medicine, inform your doctor or nurse immediately.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, contact your doctor. This includes any possible side effect not listed in this leaflet.

Allergic reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, tell your doctor or nurse immediately. Signs of allergy may include:

• Sudden breathlessness, chest pain or chest tightness.
• Swelling of the eyelids, face, lips, mouth or tongue.
• Sudden skin rash or hives anywhere on the body.
• Collapse and shock.

Contact your doctor, pharmacist, or nurse if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• Slowing of the heartbeat.
• Lowering of blood pressure.

Uncommon (may affect up to 1 in 100 people)

• Skin rash or redness of the skin.
• Breathlessness or cough.

Very rare (may affect up to 1 in 10,000 people)

• Muscle weakness or muscle pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cisatracurium Noridem

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and the carton after Scad. /EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Keep in the original container to protect the medicine from light.
• If diluted, store the infusion solution between 2 °C and 8 °C and use within 24 hours. The infusion solution must be discarded if not used within 24 hours.
• Do not dispose of medicines via wastewater or household waste. Ask your doctor or nurse how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cisatracurio Noridem contains

• The active substance is cisatracurium (as besilate).
• The other components are benzenesulfonic acid and water for injections.

Description of the appearance of Cisatracurio Noridem and pack contents
Cisatracurio Noridem is available in clear glass vials in a pack of 5 and a pack of 1.
Each 10 mL vial contains 20 mg of cisatracurium.
Each 5 mL vial contains 10 mg of cisatracurium.
Each 2.5 mL vial contains 5 mg of cisatracurium.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. INDUSTRIA FARMACEUTICA
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Cisatracurium Noridem 2 mg/ml Injektions-/Infusionslösung
Austria: Cisatracurium Noridem 2 mg/ml Injektions-/Infusionslösung
Ireland: Cisatracurium 2 mg/ml Solution for injection/infusion
Greece: CISATRAL 2 mg/ml Διάλυμα για ένεση/έγχυση
Poland: Cisatracurium Noridem
Cyprus: CISATRAL 2 mg/ml Διάλυμα για ένεση/έγχυση
Czech Republic: Cisatracurium Noridem
Denmark: Cisatracurium Noridem
Finland: Cisatracurium Noridem 2 mg/ml injektio-/infuusioneste, liuos
France: CISATRACURIUM NORIDEM 2 mg/ml, solution injectable/pour perfusion
Hungary: Cisatracurium Noridem 2 mg/ml oldatos injekció/infúzió
Italy: Cisatracurio Noridem
Netherlands: Cisatracurium Noridem 2 mg/ml oplossing voor injectie / infusie
Norway: Cisatracurium Noridem
Portugal: Cisatracúrio Noridem
Romania: Cisatracurium Noridem 2 mg/ml soluţie injectabilă/perfuzabilă
Slovak Republic: Cisatracurium Noridem 2 mg/ml injekčný/infúzny roztok
Spain: Cisatracurio Noridem 2 mg/ml solución inyectable y para perfusiónEFG
Sweden: Cisatracurium Noridem

The following information is intended exclusively for physicians or healthcare professionals:
This product is for single use only. Use only clear solutions, ranging from almost colorless to pale yellow or yellowish-green in color. The product should be inspected visually before use, and if there is any change in appearance or if the container is damaged, the product must be discarded.

When diluted to concentrations between 0.1 and 1 mg/mL, Cisatracurio Noridem is chemically and physically stable for 24 hours at 5 °C - 25 °C in the following infusion solutions or in polypropylene containers:
Sodium chloride (0.9% w/v) intravenous infusion.
Glucose (5% w/v) intravenous infusion.
Sodium chloride (0.18% w/v) and glucose (4% w/v) intravenous infusion.
Sodium chloride (0.45% w/v) and glucose (2.5% w/v) intravenous infusion.

However, since the product does not contain antimicrobial preservatives, dilution should be carried out immediately before use; otherwise, the diluted solution must be stored as indicated in section 6.3.

Cisatracurio Noridem has been shown to be compatible with the following drugs commonly used in the perioperative setting when mixed under conditions simulating intravenous infusion administration via a Y-site injection set: fentanyl citrate and midazolam hydrochloride. When other drugs are administered through the same needle or indwelling cannula as Cisatracurio Noridem, it is recommended that each drug be flushed through with an adequate volume of a suitable intravenous solution, e.g., sodium chloride intravenous infusion (0.9% w/v).

As with other drugs administered intravenously, if a small vein is selected as the injection site, Cisatracurio Noridem should be flushed through the vein with a suitable intravenous solution, e.g., sodium chloride intravenous infusion (0.9% w/v).